AstraZeneca’s Tagrisso Secures EU Approval For Advanced Lung Cancer Treatment

AstraZeneca’s Tagrisso (osimertinib) has received approval from the European Union (EU) for treating adults with locally advanced, unresectable non-small cell lung cancer (NSCLC) who have specific epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R substitutions). This approval applies to patients whose disease has not progressed during or after platinum-based chemoradiation therapy (CRT).

Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the Carlos Haya University Hospital, Malaga, Spain, and investigator for the trial, said in a statement, “Today’s approval marks a breakthrough for patients in the EU with unresectable, EGFR-mutated non-small cell lung cancer, delivering the first targeted treatment in this setting. Osimertinib reduced the risk of disease progression or death by an unprecedented 84 per cent in the LAURA trial, setting a new benchmark for outcomes and underscoring the importance of testing for EGFR mutations upon diagnosis.”

The European Commission’s decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP). It is supported by findings from the LAURA Phase III trial, published in The New England Journal of Medicine. In this trial, Tagrisso demonstrated an impressive 84% reduction in the risk of disease progression or death compared to placebo (hazard ratio 0.16; 95% CI 0.10-0.24; p<0.001). Patients receiving Tagrisso had a median progression-free survival (PFS) of 39.1 months versus just 5.6 months for the placebo group.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, stated, “Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy. The powerful results from the LAURA trial show Tagrisso improves outcomes for patients in the unresectable setting, reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer.”

While overall survival (OS) data is still maturing, the trial is ongoing to assess this as a secondary endpoint. Lung cancer remains a significant health challenge in Europe, with over 450,000 new cases annually. Around 80-85% of these are NSCLC, and approximately 10-15% of those patients have tumours with EGFR mutations. The safety profile of Tagrisso in the LAURA trial was consistent with previous findings, and no new safety concerns were identified.

This marks the fifth primary approval for Tagrisso based on the LAURA trial, following recent authorisations in the US, South Korea, Switzerland, and Australia. Regulatory reviews are also being done in countries such as China and Japan. Tagrisso is now approved in over 100 countries for various uses, including as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, adjuvant therapy for early-stage EGFR-mutated NSCLC, and in combination with chemotherapy for first-line treatment in certain regions.